ONXX receives positive recommendation from ODAC. POZN bio-equivalence of PA32540 not shown. CYTK offering. CTIC President resigns
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11-0 [with 1 abstention] in favour of Kyprolis (carfilzomib) for the treatment of relapsed and refractory multiple myeloma. The PDUFA date for accelerated approval is July 27, 2012.
Cytokinetics, Incorporated (Nasdaq: CYTK) priced two underwritten offerings for total gross proceeds of $60m.
Cell Therapeutics, Inc. (NASDAQ:CTIC) – Craig W. Philips delivered notice of his intention to resign as President of Cell Therapeutics, Inc., effective July 16, 2012.
POZEN Inc. (NASDAQ: POZN) announced that the FDA, following analyses of a Phase 1 study (115 Study), does not agree that bioequivalence of PA32540 to EC aspirin 325 mg was demonstrated. POZEN has a planned follow-up call with the FDA in the next few weeks to determine next steps in satisfying the bioequivalence requirements and any impact on the New Drug Application (NDA) filing timeline.